Flex4Sure™ 2D 250ml – 50L multi-layer PE pillow bags for the storage and handling of biopharmaceutical process solutions.
The multi-layer co-extrusion RENOLIT INFUFLEX 9101 ULDPE film used for the 2D pillow bags ensures minimized gas permeability, good physical strength, and wide chemical compatibility and biocompatibility of the aseptic storage bags, so that they can be safely used for the storage and transportation of various biopharmaceutical liquids. Standard 2D chambers with 3 ports, 250ml – 50L
Advantages • Good physical strength, chemical compatibility, and biological compatibility of film materials. • Highly transparent film materials for enhanced visual inspection of process fluids • Caterings to the needs for storage and transport of various solutions in the biopharmaceutical process • Flexible customization of configuration, allowing precise alignment with application needs; potential for customized chamber volumes
Applications • Storage and transport of small-scale buffers and culture media • Purified component collection • Sample collection and transport • Temporary storage and transportation of bulk intermediates • Collection, storage, and transport of drug substances • Transport of end products
Process flexibility is provided by various chamber volumes combined with customized tubing types, sizes, and lengths. A wide range of distal connectors are available (filters, aseptic and hygienic connectors). Manifolds can also be specified for additional process security in critical applications.
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Flex4Sure™ 2D Technical Parameters Production Data
Typical Values
Specification
250ml – 50L – 3-port
Operating temperature
0 – 60°C
Sterilization method
Gamma ray irradiation sterilization (25 – 40 kGy)
Packaging form
Double-layer PE bag vacuum packaging
Film Material Information Structure
LDPE/EVOH/ULDPE (liquid contact layer)
Thickness
0.325 mm
Compliance
ISO 10993-4: Hemolysis, ISO 10993-5: Cytotoxicity ISO 10993-6: Implantation test, ISO 10993-10: Irritation and sensitization tests ISO 10993-11: Acute Systemic Toxicity test USP<85>: Bacterial Endotoxins – LAL test on request USP<661>: Plastic containers, European Pharmacopoeia tests, Ch. 3.1.5 USP<88>: Biological reactivity testing, in vivo, Class VI USP<661>: Plastic containers, European Pharmacopoeia tests, Ch. 3.1.5 ADCF: No animal-derived ingredients
Americas
Europe & Asia
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sanisure.com Specifications subject to change without notice. Copyright SaniSure GmbH. USA, Version 02